NCT05805501进行中（未招募）2 期
A Randomized Open Label Phase II Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 199
- 试验地点
- 68
- 主要终点
- Incidence and Severity of Adverse Events (AEs)
研究概览
简要总结
This study will evaluate the safety of tobemstomig (RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and axitinib as compared to pembrolizumab and axitinib in participants with previously untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma (ccRCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- •International Metastatic RCC Database Consortium (IMDC) risk intermediate (score of 1 or 2) or poor (score of 3-6)
- •Measurable disease with at least one measurable lesion
- •Histologically confirmed ccRCC with or without sarcomatoid features
- •Negative for HIV, hepatitis B, or hepatitis C virus (HCV)
排除标准
- •Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 90 days after the final dose of tiragolumab, 4 months after the final dose of tobemstomig (RO7249669) and pembrolizumab, or for 1 week after the final dose of axitinib, whichever occurs last
- •Inability to swallow a tablet or malabsorption syndrome
- •Prior treatment for localized and/or metastatic RCC with systemic RCC-directed therapy, including T-cell costimulating or immune checkpoint blockade therapies
- •Ongoing use or anticipated need for treatment with a strong CYP3A4/5 inhibitor or inducer
- •Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •History of leptomeningeal disease
- •Uncontrolled tumor-related pain
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- •Moderate to severe hepatic impairment (Child-Pugh B or C)
- •Uncontrolled hypertension
- •Prior history of hypertensive crisis or hypertensive encephalopathy
- •Significant cardiovascular/cerebrovascular disease within 3 months (12 months for UK participants) prior to randomization
- •History of clinically significant ventricular dysrhythmias or risk factors for ventricular dysrhythmias
- •History of congenital QT syndrome
- •Resting heart rate (HR) > 100 bpm (or clinically significant tachycardia)
- •Stroke (including transient ischemic attack), myocardial infarction, or other symptomatic ischemic event, or thromboembolic event (e.g., deep venous thrombosis [DVT], pulmonary embolism [PE]) within 3 months (12 months for UK participants) before randomization
- •Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1
- •Tumors invading pulmonary blood vessels, cavitating pulmonary lesions or known endobronchial disease
- •Tumor invading the gastrointestinal (GI) tract, including abdominal or tracheoesophageal fistulas
- •Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- •Active peptic ulcer disease, acute pancreatitis, acute obstruction of the pancreatic or biliary duct, appendicitis, cholangitis, cholecystitis, diverticulitis, gastric outlet obstruction
- •Intra-abdominal abscess within 6 months before initiation of study treatment
- •Clinical signs or symptoms of GI obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
- •Evidence of bleeding diathesis or significant coagulopathy
- •Grade ≥ 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment
- •Clinically significant hematuria, hematemesis, hemoptysis of > 0.5 teaspoon (2.5 mL) of red blood, coagulopathy, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 3 months before initiation of study treatment
- •Active or history of autoimmune disease or immune deficiency
- •Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
- •Prior allogeneic stem cell or solid organ transplantation
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •History of another primary malignancy other than RCC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%)
- •Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live, attenuated vaccine will be required during the study
- •Active tuberculosis (TB)
- •Severe infection within 4 weeks prior to initiation of study treatment
- •Participants with active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
- •Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- •Known hypersensitivity to Chinese hamster *ovary cell products or to any component of tobemstomig, tiragolumab, pembrolizumab, or axitinib
研究组 & 干预措施
Control Arm (Pembrolizumab + Axitinib)
Active Comparator
Participants will receive IV pembrolizumab Q3W on Day 1 of each 21-day cycle. Participants will also receive axitinib PO BID.
干预措施: Pembrolizumab (Drug)
Control Arm (Pembrolizumab + Axitinib)
Active Comparator
Participants will receive IV pembrolizumab Q3W on Day 1 of each 21-day cycle. Participants will also receive axitinib PO BID.
干预措施: Axitinib (Drug)
Arm A (Tobemstomig + Axitinib)
Experimental
Participants will receive intravenous (IV) tobemstomig every three weeks (Q3W) on Day 1 of each 21-day cycle. Participants will also receive oral (PO) axitinib twice daily (BID).
干预措施: Axitinib (Drug)
Arm B (Tobemstomig + Tiragolumab + Axitinib)
Experimental
Participants will receive IV tobemstomig followed by IV tiragolumab Q3W on Day 1 of 21-day cycle. Participants will also receive axitinib PO BID.
干预措施: Tiragolumab (Drug)
Arm A (Tobemstomig + Axitinib)
Experimental
Participants will receive intravenous (IV) tobemstomig every three weeks (Q3W) on Day 1 of each 21-day cycle. Participants will also receive oral (PO) axitinib twice daily (BID).
干预措施: Tobemstomig (Drug)
Arm B (Tobemstomig + Tiragolumab + Axitinib)
Experimental
Participants will receive IV tobemstomig followed by IV tiragolumab Q3W on Day 1 of 21-day cycle. Participants will also receive axitinib PO BID.
干预措施: Tobemstomig (Drug)
Arm B (Tobemstomig + Tiragolumab + Axitinib)
Experimental
Participants will receive IV tobemstomig followed by IV tiragolumab Q3W on Day 1 of 21-day cycle. Participants will also receive axitinib PO BID.
干预措施: Axitinib (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events (AEs)
时间窗: Up to a maximum of 2 years
次要结局
未报告次要终点
研究者
研究点 (68)
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